Harmonisation of Pharmacopoeial Requirements for Identification of Closely Related Species in Herbal Medicinal Products

Global interest in herbal medicinal products is growing, thus increasing the demand for medicinal plant raw materials. However, the growth in sales of raw materials entails the risk of a wider spread of counterfeit and substandard medicinal products. The use of such products can lead to serious complications and even death. This brings to the forefront the studies aiming at identification and quality control of herbal drugs. In addition, the relevance of these studies stems from the need for harmonisation of test methods for identification of related plant species as acceptable foreign elements in herbal medicinal products. The aim of the study was to determine the most widely used methods for identification of closely related plant species and to analyse the possibility of aligning the requirements of Russian standards and foreign pharmacopoeial monographs. According to the analysis of identification requirements, the main test method for identification of related plant species is thin-layer chromatography; morphological and anatomical characteristics of plants are also used. Methodological approaches of the European Pharmacopoeia to identification of closely related species in herbal medicinal products have found application in updating compendial standards of the Russian Pharmacopoeia. Russian standards are harmonised with the requirements described in monographs of leading pharmacopoeias and provide for the detection of unacceptable impurities in herbal medicinal products by morphological, anatomical and chromatographic characteristics.

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